Public HealthClinical Trial At The Cancer Institute Of New Jersey Focuses On New Treatment Combination For Most Common Type Of Non-Invasive Breast Cancer
Researchers at The Cancer Institute of
New Jersey (CINJ) have launched a clinical trial that targets a new
treatment combination for the most common type of non-invasive breast
cancer known as ductal carcinoma in situ (DCIS). CINJ is a Center of
Excellence of UMDNJ-Robert Wood Johnson Medical School.
In DCIS, the cancer cells are inside the milk ducts of the breast but have
not spread to surrounding breast tissue. According to the American Cancer
Society, one in five new breast cancer cases in the United States is
diagnosed as DCIS, and nearly all diagnosed at this early stage can be
cured.
The trial, sponsored by the National Surgical Adjuvant Breast and Bowel
Project (NSABP), will compare the effects of adding the drug trastuzumab
to radiation therapy following breast sparing surgery (lumpectomy) in
patients whose DCIS makes too much of the protein known as HER2
(positive). Too much of this protein can cause a normal cell to turn
cancerous and make existing cancer cells grow faster. Trastuzumab is
considered a targeted therapy against HER2-positive breast cancer. Early
information shows the drug may also help radiation therapy work better in
treating HER2-positive breast cancer, although investigators caution more
research is needed in this area.
Trastuzumab has approval from the U.S. Food and Drug Administration (FDA)
for the treatment of HER2-positive breast cancer together with
chemotherapy, but it is considered "investigational" in this trial,
because its use in combination with radiation therapy has not been FDA
approved. The primary aim of this study is to see if this new combination
is more effective in preventing occurrence of DCIS in the same breast or
in other parts of the body, versus giving radiation by itself following
lumpectomy.
Antoinette R. Tan, MD, a medical oncologist at CINJ and assistant
professor of medicine at UMDNJ-Robert Wood Johnson Medical School, is the
lead investigator of the study at CINJ. "A previous study by the NSABP
shows an overall recurrence rate of eight percent in this population 12
years following breast conserving surgery and radiation. If we can add
another element to the standard treatment, we could possibly reduce that
rate even further," she said. The study is seeking 2,000 participants at
multiple cancer centers across the country.
Before taking part in the trial, interested participants will undergo a
physical exam and a mammogram. Of those selected, one group will receive
radiation therapy for three to six weeks as part of their regular
treatment following surgery, while the other group will receive both
radiation treatment and trastuzumab, which will be given through
injection. Following treatment, participants will have follow-up physical
exams and a mammogram each year for the next ten years.
Women over age 18 who have been diagnosed with HER2-positive DCIS and have
had a lumpectomy are eligible to participate, although other criteria also
must be met. For more information on how to take part, individuals should
call CINJ"s Office of Human Research Services at 732-235-8675.
Clinical trials, often called cancer research studies, test new treatments
and new ways of using existing treatments for cancer. At CINJ,
researchers use these studies to answer questions about how a treatment
affects the human body and to make sure it is safe and effective. There
are several types of clinical trials currently underway at CINJ, including
those that diagnose, treat, prevent, and manage symptoms of cancer. Many
treatments used today, whether drugs or vaccines; ways to do surgery or
give radiation therapy; or combinations of treatments, are the results of
past clinical trials.
As New Jersey"s only National Cancer Institute-designated Comprehensive
Cancer Center, CINJ offers patients access to treatment options not
available at other institutions within the state. CINJ currently enrolls
more than 1,000 patients on clinical trials, including approximately 15
percent of all new adult cancer patients and approximately 70 percent of
all pediatric cancer patients. Enrollment in these studies nationwide is
fewer than five percent of all adult cancer patients.
The Cancer Institute of New Jersey